Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation

NCT06942013 | Not Yet Recruiting

• 1 other identifier: Cortical Shell Technique
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The protocol outlines a randomized clinical trial comparing two surgical techniques for horizontal ridge augmentation in the anterior mandible: Computer-Guided Autogenous Cortical Shell Technique (using a patient-specific guide for precise placement). Free-Hand Autogenous Cortical Shell Technique (traditional approach without a guiding template). Key Points: The study aims to determine which method provides better accuracy and bone volume stability. Cone Beam CT scans (CBCT) will assess horizontal bone gain preoperatively and six months postoperatively. The trial is conducted at Cairo University's Faculty of Dentistry. Participants: Patients with pure horizontal bone loss in the anterior mandible. Outcomes: Primary: Bone width gain in millimeters. Secondary: Accuracy of augmentation and surgical time. Methodology: The study group will use computer-designed surgical osteotomy guides to harvest and place bone grafts with improved precision. The control group will rely on the conventional free-hand approach. Both groups will undergo bone grafting using autogenous cortical bone shells. Data Collection \& Analysis: Participants will be randomized and blinded. Data will be analyzed using statistical methods to compare effectiveness.

Conditions

Horizontal Ridge Deficiency

Outcome Measures

Primary Outcomes (1)

• Alveolar Ridge Horizontal Bone Gain

  measure the amount of horizontal bone gain achieved at the anterior mandibular ridge following horizontal ridge augmentation using either the computer-guided autogenous cortical shell technique or the free-hand technique.

  (CBCT) scans are taken preoperatively and 6 months postoperatively to evaluate bone changes. Superimposition of CBCT images is performed using Mimics 21.0 software (Materialise, Belgium) to assess bone augmentation

Secondary Outcomes (2)

• Accuracy of the Computer-assisted guide in the study group

  Measured at: 6 months postoperatively using CBCT scans.

• Intraoperative Time

  During surgery by using a stopwatch.

Study Arms (2)

Full Digital Workflow

EXPERIMENTAL

Study Group (Computer-Guided Autogenous Cortical Shell Technique) Bone harvesting and fixation are done using patient-specific guides , chin harvesting guide and bone block fixation guide. Uses a 3D-printed, patient-specific surgical guide for precise bone harvesting and placement. Piezo drill cuts are guided to ensure accurate osteotomy and graft positioning. The labial cortical shell is fixated using pre-planned screw holes for better stability. Bone particulate grafting (autogenous + xenograft, 50:50) is packed into the defect. Enhances accuracy, reduces surgical time, and minimizes complications

Device: Computer-Guided Autogenous Cortical Shell Technique (Study Group)

Free Hand Protocol

ACTIVE COMPARATOR

Control Group (Free-Hand Autogenous Cortical Shell Technique) Bone harvesting and fixation are done manually, relying on the surgeon's experience. Osteotomy is performed free-hand, increasing the risk of inaccurate graft placement. The labial cortical shell is manually fixated, potentially leading to misalignment. Bone particulate grafting (autogenous + xenograft, 50:50) is used, similar to the study group. Higher risk of human error, longer surgical time, and greater variability in outcomes

Procedure: Free-Hand Autogenous Cortical Shell Technique (Control group)

Interventions

Computer-Guided Autogenous Cortical Shell Technique (Study Group) DEVICE

This study utilizes two patient-specific 3D-printed surgical guides to enhance precision in bone harvesting and fixation for horizontal ridge augmentation in the anterior mandible. Chin Harvesting Guide This tooth-supported guide is placed on the exposed mandibular symphysis to ensure accurate osteotomy cuts for harvesting a cortical bone shell. It directs piezo drill cuts (superior, inferior, and vertical) to minimize errors and prevent damage to vital structures. Bone Block Fixation Guide After harvesting, this guide helps in precise fixation of the cortical shell onto the recipient site. It includes pre-planned screw holes to ensure stable positioning of the graft and improve surgical accuracy. These guides enhance precision, reduce surgical time, and improve graft stability, making the computer-guided technique superior to the traditional free-hand method.

Full Digital Workflow

Free-Hand Autogenous Cortical Shell Technique (Control group) PROCEDURE

In this group, horizontal ridge augmentation of the anterior mandible is performed using a free-hand technique without computer-guided assistance. Autogenous cortical bone is harvested from the mandibular symphysis using a conventional osteotomy performed manually. The harvested cortical shell is adapted and fixated at the recipient site using titanium mini screws, based on the surgeon's clinical judgment and intraoperative assessment. Bone particulate grafting using a 1:1 ratio of autogenous bone and xenograft material is packed into the defect to enhance volume stability. This approach may result in increased variability in graft positioning, longer surgical time, and higher dependence on surgeon experience.

Free Hand Protocol

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Anterior mandible with horizontal deficient alveolar ridge that is from 2 to 4 mm measured from the crest of the alveolar ridge buccolingually.
• Class IV and V according to Cawood and Howell classification.
• No sex predilection.
• Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.
• The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.
• Normal vertical dimension with normal inter-arch space.

You may not qualify if:

• Intra-bony lesions (e.g. cysts) or infections (e.g. abscess) that may retard the osteotomy healing.
• General contraindications to implant surgery.
• Subjected to irradiation in the head and neck area less than 1 year before implantation.
• Untreated periodontitis.
• Poor oral hygiene and motivation.
• Uncontrolled diabetes.
• Pregnant or nursing females.
• Immunosuppressed or immunocompromised
• Heavy smokers
• Patients who undergo medication interfere with bone healing
• Previous grafting procedures in the edentulous area.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This trial is considered a randomized single blind clinical trial due to the following: 1. The participants will be blinded to the technique that will be used during the surgical procedure. 2. The operator (M.E.) will not be blinded for both techniques during the surgical procedure as the two techniques are different. 3. The outcome assessor (Dr. S.H.) cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Type: Parallel, two arms, randomized controlled trial Allocation ratio: 1:1 Framework: Equivalence

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share